Prescribed daily dosage amounts of fiber are often high, such that the patient must administer the fiber or fiber composition several times per day. Numerous fiber-containing products are available in the market in the form of breakfast cereals, laxative beverages, bran tablets and cereal bars. While the health benefits of fiber consumption are now well known to the general public, and the public has accepted the desirability of increased fiber consumption, the unpleasant fibrous mouthfeel and texture of the currently available fiber-containing products has resulted in dosage compliance problems.
Many fiber markets have experienced consumer reluctance to eat sufficient amounts of fiber to provide therapeutic benefits because of the generally objectionable taste of the fiber or the high caloric content associated with masking the objectionable taste. The dry, unpalatable texture and mouthfeel of fiber often requires the incorporation of fats and carbohydrates (masking agents) in amounts which effectively dilute the fiber dosage per unit of product and substantially increase the caloric content of the product.
Commercially available confectionery products containing fiber are generally of the granola-type. Chocolate, fruits and nuts are often added with other confectionery ingredients to enhance the palatability of the final product. Snack meals consisting of granola-type bars and cookies have become increasingly popular among health-conscious consumers as a substitute for traditional meals. Although these forms of fiber-containing products are generally more pleasant tasting, they typically do not deliver the high concentration of fiber necessary to achieve optimum dosage. Moreover, inasmuch as these products have a high sugar content (typically up to about 70% added sugars), they are contrary to the health conscious consumer's desire to avoid refined sugars, as well as those persons, such as diabetics, who must also avoid and/or restrict their intake of sugars and sugar-containing products.
Inadequate patient compliance with prescribed drug therapies is another problem, particularly when the drug has an unpleasant taste, after-taste or gritty mouthfeel. Drugs such as phenolphthalein, dextromethorphan, danthron, sennosides, cholestyramine and potassium chloride are known to taste unpleasant. The prior art has disclosed products to mask the taste of these drugs, but the products themselves often suffer from their own unpleasant tastes or texture.
The overall trend, therefore, in patient use of the prior art products containing fiber or drugs, has been to deviate from the prescribed dosage or frequency of dosage, thereby diminishing the effectiveness of the therapy.
In a related disclosure, U.S. Pat. No. 4,698,232 to Sheu et al., a unique confectionery form for delivering fiber is provided which includes elements of nougat technology, boiled candy technology and coating technology, to achieve an acceptable composition containing about 20% to 30% dietary fiber. The solution provided in the above-referenced patent is excellent if the consumer finds the foam-type matrix described therein desirable.
In another related disclosure, U.S. application Ser. No. 032,840, filed Mar. 31, 1987, a unique sugar-containing pectin gel delivery system is provided which includes a pectin gel component in an amount sufficient to form a gel confectionery unit and an edible insoluble solid. This delivery system is a viable and pleasant alternative for consumers seeking to increase their intake of dietary fiber who enjoy a gel-type matrix. This delivery system includes the use of sugar, such as sucrose, and corn syrup and, accordingly, is not suitable for consumers seeking to avoid sugar by consuming sugarless products. Moreover, it was found that the direct replacement of hydrogenated starch hydrolysates for the sucrose/corn syrup components of the sugar pectin gel did not yield an acceptable sugarless pectin gel delivery system product. Direct replacement resulted in a confectionery gel product having a higher than suitable water activity which rendered the product unstable with respect to microbial activity. Merely decreasing the water content of the direct replacement sugarless pectin gel in an attempt to avoid this problem caused additional problems. There was a significant increase in the depositing viscosity of the delivery system, thereby rendering the molten mix not flowable for deposition into the mold cavities, and a tougher, more rubbery textured final product. Accordingly, direct replacement of hydrogenated starch hydrolysates for the sugar/corn syrup component of the prior art resulted in a variety of completely different problems and a commercially unusable product.
Two patents which disclose palatable drug formulations use coacervation techniques to combine cholestyramine with modified celluloses. U.S. Pat. No. 3,947,272 shows oral palatable formulations containing aqueous media and cholestyramine. A method of treating hypercholesterolemia is claimed. Chewable products containing cellulosic/gum colloids are disclosed.
U.K. Pat. No. 1,446,352 concerns palatable compositions useful for the treatment of hypercholesterolemia and biliary cirrhosis. The invention provides a liquid composition containing "coacervate of cholestyramine with a cellulose hydrocolloid" derivative. By the term "coacervate" is meant the coagulation of two hydrophilic substances of opposite charge. Representative hydrocolloids are methyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose. A water-insoluble dispersing agent, e.g., a substituted carboxymethyl starch, is optional. In making the composition, 1 part by weight of hydrocolloid is combined with 4 to 10 parts of cholestyramine by dry mixing and passing through a No. 80 U.S. standard mesh screen. The resulting powder is then mixed with a liquid to form a coacervate which can be orally administered.
In another related disclosure, U.S. application Ser. No. 698,511, filed Feb. 5, 1985, problems associated with organoleptic acceptability of fiber and drugs are remedied by formation of an aggregate having a particle size of about 4 to about 70 standard mesh. The aggregate includes a substantially anhydrous pre-swelled hydrocolloid and a substrate. Unpleasant taste and undesirable mouthfeel of fiber and/or drug is effectively masked and substantial hydration is delayed until the composition passes through the oral cavity.
It is well-known and generally accepted that the pectin-type gel system possesses premium, preferred organoleptic qualities, that is, these gels have a most tender and desirable chew character. However, although gel systems might provide an acceptable alternative delivery system, several features of gel manufacturing technology and characteristics of the resultant product discourage the use of an otherwise appealing delivery system. For example, normal gel production requires several steps generally including cooking or concentrating, depositing or molding, drying or stoving, removal from starch molds, cleaning of the product, sieving and drying the mold material, and sugar sanding, sugar crystallizing or glazing of the final product. Stoving is the process whereby deposited gels and other similar products lose moisture to obtain their desired final solids content (inverse of the moisture content) because these products would typically be to viscous to deposit if concentrated to their desired final solids content prior to deposition. In addition, uniform distribution of the active throughout the gel product may require addition of the active before cooking or addition of the active while the cooked gel is still in the molten state. Cooking will cause heat-sensitive actives to undergo thermal and/or hydrolytic degradation. Thus, from a production standpoint, a gel dosage delivery system is considered much too labor-, equipment-, time-, and energy-intensive. Furthermore, it is well known that many gels resist compete dissolution in an aqueous environment and little, if any, control can be provided to the release of a unit dosage of active ingredient from the gel.
It has now been discovered, however, that the drawbacks generally occasioned by inclusion of fiber and drugs into gel-type systems are significantly reduced and, in some cases, completely obviated by providing a gel delivery system which utilizes the natural aqueous environment of the oral cavity to mask and accelerate passage of the dissolved active ingredients during ingestion. Furthermore, the problems associated with the laborious process for preparing a suitable gel product have been overcome. In addition, the problems encountered by the direct replacement of hydrogenated starch hydrolysate for the sucrose/corn syrup component of the sugar pectin gel delivery systems have now been overcome. Thus, a sugarless pectin gel-like confectionery delivery system having a desirable chew character is now achievable.